The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Wheezing\Coughing Babies

NCT ID: NCT00512382

Last Updated: 2011-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-09-30

Brief Summary

GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the same patient by chance alone. Research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality. Therefore we conducted an observational study To determine the primary cause (RS or GER)using for the first time both PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes cough/wheeze recordings it points to GER being the possible precipitating factor and vice versa.

Detailed Description

GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the same patient by chance alone. Research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality. Therefore we conducted an observational study To determine the primary cause (RS or GER)using for the first time both PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes cough/wheeze recordings it points to GER being the possible precipitating factor.However, If cough/wheeze precedes GER recordings it points to cough/wheeze being the possible precipitating factor. The recordings will be investigated 1 minute before and one minute after each event.

Conditions

Asthma; Cough; Wheezing

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

A

Babies and small children 1-24 months

WEEM - Wheezy Monitoring

Intervention Type: DEVICE

loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.

B

Children 2-18 years old

WEEM - Wheezy Monitoring

Intervention Type: DEVICE

loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.

Interventions

WEEM - Wheezy Monitoring

loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children 1 month - 18 years old
• Difficult to treat asthma
• Difficult to treat cough
• Difficult to treat other respiratory symptoms

Exclusion Criteria

• Children on artificial ventilation
• Children not compliant with PH-Metria and/or WEEM

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wolfson Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Avigdor Mandelberg

Director, Pediatric Pulmonry Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Avigdor Mandelberg, MD

Role: STUDY_DIRECTOR

Edith Wolfson Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel aviv

Locations

Wolfson Medical center and Sackler School of Medicine, Tel Aviv University, Tel

Holon, , Israel

Countries

Israel

Other Identifiers

688 special

Identifier Type: -

Identifier Source: org_study_id